- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01467635
EBUS-TBNA Versus EBUS-TBNB
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Heidelberg, Germany, D-69126
- Thoraxklinik, University of Heidelberg
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-
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London, United Kingdom, SW10 9NH
- Chelsea and Westminster Hospital
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London, United Kingdom, SW3 6NP
- The Royal Brompton Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Scheduled for EBUS-TBNA as part of clinical care
- Lymph nodes larger than 10mm in diameter
- Age > 18 years
- Able to provide written informed consent
Exclusion Criteria:
- Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- Inability to obtain informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: EBUS-TBNA
Sampling using endobronchial ultrasound guided transbronchial needle aspiration
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Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
Other Names:
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Experimental: EBUS-TBNB
Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.
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Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
Time Frame: 18 months
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The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below:
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18 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in the complication rate between the two study arms
Time Frame: 24 months
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24 months
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Collaborators and Investigators
Investigators
- Study Director: Zaid Zoumot, MBBS, MRCP, MSc, Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust
- Principal Investigator: Pallav L Shah, MD, FRCP, Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011PA002B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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